The most frequently observed undesirable effects are nausea, vomiting and flushing. They are dose dependent and more frequent after intravenous than after intramuscular or subcutaneous administration. Adverse drug reactions from multiple sources including clinical trials and post- marketing experience are listed by MedDRA system organ class.
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common:
Malignancy (with long term use).
Immune system disorders Uncommon:
Hypersensitivity.
Very rare:
Serious allergic-type reactions such as bronchospasm, swelling of the tongue and throat, anaphylactic shock. 3 Not known: Hypocalcemia.
Nervous system disorders Common:
Dizziness, headache, dysgeusia.
Not known:
Tremor.
Eye disorders Uncommon:
Visual disturbance. 4 Uncommon: Hypertension. 2 Common: Diarrhoea, abdominal pain.
Skin and subcutaneous tissue disorders Uncommon:
Rash generalised, pruritus.
Not known:
Urticaria.
Musculoskeletal and connective tissue disorders Common:
Musculoskeletal pain including arthralgia.
Renal and urinary disorders Uncommon:
Polyuria.
General disorders and administration site conditions Common:
Fatigue.
Uncommon:
Influenza-like symptoms, oedema (facial, peripheral and generalised), injection site reaction. 1 The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. 1 Development of neutralising antibodies to calcitonin.
The development of these antibodies is not usually related to loss of clinical efficacy, although their presence in a small percentage of patients following long-term therapy with calcitonin may result in a reduced response to the product.
The presence of antibodies appears to bear no relationship to allergic reactions, which are rare. Calcitonin receptor down- regulation may also result in a reduced clinical response in a small percentage of patients following long-term therapy.
2 Nausea with or without vomiting is noted in approximately 10% of patients treated with calcitonin. The effect is more evident on initiation of therapy and tends to decrease or disappear with continued administration or a reduction in dose.
An antiemetic may be administered, if required. Nausea/vomiting are less frequent when the injection is done in the evening and after meals. 3 In case of patients with high bone remodelling (Paget’s disease and young patients) a transient decrease of calcemia may occur between the 4th and the 6th hour after administration, usually asymptomatic.
4 Flushing (facial or upper body) is not an allergic reaction but is due to a pharmacological effect, and is usually observed 10 to 20 minutes after administration. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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